Registration Dossier

Toxicological information

Developmental toxicity / teratogenicity

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Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Highest dose was too high.

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1990
Reference Type:
other: OECD SIDS
Title:
1-Chloro-2-nitrobenzene, CAS: 88-73-3
Author:
OECD SIDS
Year:
2001
Bibliographic source:
SIDS Initial Assessment Report for SIAM 13
Reference Type:
other: US EPA Status Report
Title:
Unnamed
Year:
1990

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
25 females/group, due to severe maternal toxicity and mortality the 150 mg/kg bw/day level was terminated prior to scheduled sacrifice.
GLP compliance:
yes
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Purity: commercial

Test animals

Species:
rat
Strain:
Sprague-Dawley

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
days 6-15 of gestation
Duration of test:
21 days
Doses / concentrations
Remarks:
Doses / Concentrations:
0, 25, 75, 150 mg/kg bw
Basis:
nominal conc.
No. of animals per sex per dose:
25 females/dose
Control animals:
yes, concurrent vehicle

Results and discussion

Results: maternal animals

Maternal developmental toxicity

Details on maternal toxic effects:
Details on maternal toxic effects:
Mortality:
At 150 mg/kg all dams were terminated prior to scheduled sacrifice because of severe toxicity and high mortality
At 75 mg/kg 1 dam died.

General toxicity:
At 75 mg/kg: between gestation days 6-10 reduced body weight gain (slight but not significant) and reduced food consumption; recovery later in gestation; urinary staining, alopecia; maternal reproductive parameters comparable to controls, mean number of early resorptions and post implantation loss slightly increased (post implantation loss in the respective control very low compared to historical control; values range: 0-0.9).
At 25 mg/kg: no evidence of maternal toxicity.

Effect levels (maternal animals)

open allclose all
Dose descriptor:
NOAEL
Effect level:
ca. 25 mg/kg bw/day (nominal)
Based on:
test mat.
Basis for effect level:
other: maternal toxicity
Dose descriptor:
NOAEL
Based on:
test mat.
Basis for effect level:
other: developmental toxicity

Results (fetuses)

Details on embryotoxic / teratogenic effects:
Details on embryotoxic / teratogenic effects:
Fetal body weight comparable to control.
Variations: cervical #7 ribs at 25 mg/kg bw/day (1.1%) and significant at 75 mg/kg (2%); 13 full pairs of ribs with lumbar #1 rudimentary ribs in controls, at 25 mg/kg, 75 mg/kg increased, but not significant; 12 full pair of ribs with #13 unilateral full rib and/or rudimentary rib(s) in controls and in 25 mg/kg increased, but not significant

A NOAEL for developmental toxicity could not be conclusively derived.

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Applicant's summary and conclusion